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AHA Responds to FDA Request for Input on Development of 21st Century Cures Act Section ...
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Fusion42 · 13 August 2026 · Fusion42 review
The American Hospital Association (AHA) provided input to the FDA on Section 3060 of the 21st Century Cures Act, urging permanent adoption of enforcement discretion for single clinical recommendation decision support software and clarifications on general wellness product guidance to ensure patient safety amid evolving digital health technologies.
This Wire brief sits within Fusion42's coverage of Healthtech Infrastructure.
◆ ◆ The Wire takeaway
You face a changing regulatory path for clinical decision support software that can ease product development and market entry now that the FDA may permanently relax rules on single recommendation tools. Clarify your product claims and patient safety messaging in wellness tech to stay ahead of evolving FDA guidelines.
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1 source · 13 Aug 2026
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